← Alert archive

MHRA alerts issued in 2018

90 alerts.

• Field Safety Notice - 17 - 21 December 2018

  24 Dec 2018 · Field safety notice (devices)

• Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO – Risk of total loss of patient ventilation (MDA/2018/037)

  21 Dec 2018 · Device safety information

• Field Safety Notice - 10 - 14 December 2018

  18 Dec 2018 · Field safety notice (devices)

• Field safety notices - 03 to 07 December 2018

  10 Dec 2018 · Field safety notice (devices)

• Field safety notices - 26 to 30 November 2018

  4 Dec 2018 · Field safety notice (devices)

• Class 2 Medicines Recall: Teva UK Limited and Mylan - recall of some Valsartan containing products

  30 Nov 2018 · Medicines recall/notification

  Class 2
• Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.

  29 Nov 2018 · Device safety information

• Field Safety Notice - 19 November to 23 November 2018

  26 Nov 2018 · Field safety notice (devices)

• Field Safety Notice - 12 November to 16 November

  19 Nov 2018 · Field safety notice (devices)

• All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035)

  14 Nov 2018 · Device safety information

• Mitomycin-C Kyowa: Company-led Drug Alert

  12 Nov 2018 · Medicines recall/notification

• Field Safety Notice - 05 November to 09 November

  12 Nov 2018 · Field safety notice (devices)

• Field Safety Notice - 29 October to 02 November

  5 Nov 2018 · Field safety notice (devices)

• Field Safety Notice - 22 October to 26 October

  30 Oct 2018 · Field safety notice (devices)

• Field Safety Notice - 15 October to 19 October

  22 Oct 2018 · Field safety notice (devices)

• Field Safety Notice - 8 October to 12 October

  15 Oct 2018 · Field safety notice (devices)

• Field Safety Notice - 1 October to 5 October

  8 Oct 2018 · Field safety notice (devices)

• Class 2 Medicines Recall: Ozurdex 700 micrograms intravitreal implant in applicator manufactured by Allergan Pharmaceuticals Ireland (MDR 95-08/18)

  5 Oct 2018 · Medicines recall/notification

  Class 2
• Field Safety Notice - 24 September to 28 September

  1 Oct 2018 · Field safety notice (devices)

• Field Safety Notice - 17 September to 21 September

  24 Sept 2018 · Field safety notice (devices)

• Imatinib 400mg Capsules (3 x 10) PL 36390/0180 : Company-led Drug Alert

  21 Sept 2018 · Medicines recall/notification

• Class 4 defect information: Caspofungin 70mg powder for concentrate for solution for infusion (MDR 11-09/18)

  18 Sept 2018 · Medicines recall/notification

  Class 4
• Field Safety Notice - 10 September to 14 September

  17 Sept 2018 · Field safety notice (devices)

• Mydriasert 0.28mg/5.4mg Ophthalmic Insert: Company-led recall

  11 Sept 2018 · Medicines recall/notification

• Field safety notices - 03 to 07 September 2018

  10 Sept 2018 · Field safety notice (devices)

• Field Safety Notice - 28 to 31 August

  3 Sept 2018 · Field safety notice (devices)

• Class 4 defect information: Olmetec 20mg Film Coated Tablets (MDR 12-08/18)

  3 Sept 2018 · Medicines recall/notification

  Class 4
• Field Safety Notice - 20 to 24 August

  28 Aug 2018 · Field safety notice (devices)

• Nutriflex Lipid Special without Electrolytes 2500ml: Company-led recall

  23 Aug 2018 · Medicines recall/notification

• Nutriflex Omega Special 2500ml: Company-led recall

  20 Aug 2018 · Medicines recall/notification

• Field Safety Notice - 13 August to 17 August

  20 Aug 2018 · Field safety notice (devices)

• Field Safety Notice - 6 August to 10 August

  13 Aug 2018 · Field safety notice (devices)

• Field Safety Notice - 30 July to 3 August

  6 Aug 2018 · Field safety notice (devices)

• Field Safety Notice - 23 to 27 July 2018

  30 Jul 2018 · Field safety notice (devices)

• Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17)

  30 Jul 2018 · Medicines recall/notification

  Class 3
• Breast implants, all types, makes and models – Continue to report suspected cases of Breast Implant Associated - Anaplastic Large Cell Lymphoma (MDA/2018/027)

  25 Jul 2018 · Device safety information

• Field safety notices - 16 to 20 July 2018

  23 Jul 2018 · Field safety notice (devices)

• Melatonin 10mg capsules: Company-led recall

  17 Jul 2018 · Medicines recall/notification

• Field safety notices - 09 to 13 July

  16 Jul 2018 · Field safety notice (devices)

• Field safety notices - 2 to 6 July 2018

  9 Jul 2018 · Field safety notice (devices)

• Class 2 Medicines Recall: Fiasp FlexTouch 100 units/mL solution for injection pre-filled pen manufactured by Novo Nordisk (MDR 065-06/18)

  9 Jul 2018 · Medicines recall/notification

  Class 2
• Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall

  5 Jul 2018 · Medicines recall/notification · EL (18)A/11

  Class 1
• Field safety notices - 25 to 29 June 2018

  2 Jul 2018 · Field safety notice (devices)

• Field Safety Notice - 18 to 22 June 2018

  25 Jun 2018 · Field safety notice (devices)

• Denzapine 50mg/ml Oral Suspension - company led recall

  25 Jun 2018 · Medicines recall/notification

• Field Safety Notice - 11 to 15 June 2018

  20 Jun 2018 · Field safety notice (devices)

• Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046

  19 Jun 2018 · Medicines recall/notification · EL (18)A/09

  Class 4
• Class 2 Medicines Recall: Own-brand children’s glycerine and blackcurrant cough syrups manufactured by Bell, Sons & Co.

  19 Jun 2018 · Medicines recall/notification

  Class 2
• Field Safety Notice - 04 to 08 June 2018

  11 Jun 2018 · Field safety notice (devices)

• Field safety notices - 28 May to 1 June 2018

  4 Jun 2018 · Field safety notice (devices)

• Field safety notices - 21 - 25 May 2018

  30 May 2018 · Field safety notice (devices)

• Field Safety Notice - 14 to 18 May 2018

  24 May 2018 · Field safety notice (devices)

• Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension - company led recall

  16 May 2018 · Medicines recall/notification

• Gambro Ultrafilter U9000 microbial water filter – updated instructions due to leaks during use resulting in risk of hypovolemia.

  16 May 2018 · Device safety information

• Field Safety Notice - 07 to 11 May 2018

  14 May 2018 · Field safety notice (devices)

• Field Safety Notice - 30 April to 04 May 2018

  8 May 2018 · Field safety notice (devices)

• Class 3 Medicines Recall: Latanoprost Timolol Eye drops

  2 May 2018 · Medicines recall/notification

  Class 3
• Field Safety Notice - 23 to 27 April 2018

  30 Apr 2018 · Field safety notice (devices)

• Field Safety Notice - 16 to 20 April 2018

  19 Apr 2018 · Field safety notice (devices)

• Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)

  18 Apr 2018 · Medicines recall/notification · EL (18)A/07

  Class 4
• Field Safety Notice - 9 to 13 April 2018

  13 Apr 2018 · Field safety notice (devices)

• Field Safety Notice - 02 to 06 April 2018

  9 Apr 2018 · Field safety notice (devices)

• Field Safety Notice - 26 to 30 March 2018

  3 Apr 2018 · Field safety notice (devices)

• Mesna 100mg/ml solution for injection/infusion, 5 x 4ml - company led recall

  28 Mar 2018 · Medicines recall/notification

• Field Safety Notice - 19 to 23 March 2018

  26 Mar 2018 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules, PL 46302/0149 (EL (20)A/18)

  24 Mar 2018 · Medicines recall/notification · EL (20)A/18

  Class 4
• Field Safety Notice - 12 to 16 March 2018

  20 Mar 2018 · Field safety notice (devices)

• Field Safety Notice - 5 to 9 March 2018

  12 Mar 2018 · Field safety notice (devices)

• Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)

  12 Mar 2018 · Medicines recall/notification

  Class 3
• Medical device alerts archived in March 2018

  6 Mar 2018 · Device safety information

• Field Safety Notice - 26 February – 02 March 2018

  5 Mar 2018 · Field safety notice (devices)

• Field Safety Notice - 19 to 23 February 2018

  26 Feb 2018 · Field safety notice (devices)

• Class 4 Medicines Defect Information: Bleo-Kyowa, powder for solution for injection, 15,000 IU

  22 Feb 2018 · Medicines recall/notification

  Class 4
• Aquilon series of nebulisers – CE mark withdrawn and supply ceased

  22 Feb 2018 · Device safety information

• Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate)

  21 Feb 2018 · Medicines recall/notification · EL (18)A/03

  Class 2
• Class 2 Medicines Recall: Seretide Accuhaler 50 microgram/250 microgram/dose inhalation powder, pre-dispensed

  21 Feb 2018 · Medicines recall/notification · EL (18)A/04

  Class 2
• Field Safety Notice - 12 to 16 February 2018

  19 Feb 2018 · Field safety notice (devices)

• Plum 360 infusion pumps – user actions required to prevent risk of interrupted infusion or delay to treatment

  15 Feb 2018 · Device safety information

• Field Safety Notice - 5 to 9 February 2018

  12 Feb 2018 · Field safety notice (devices)

• Field Safety Notice - 29 January - 2 February 2018

  6 Feb 2018 · Field safety notice (devices)

• Class 2 Medicines Recall: Magnevist and Omniscan Solutions for injection EL (18) A/02

  1 Feb 2018 · Medicines recall/notification · EL (18)A/02

  Class 2
• Class 2 Medicines Recall: Macleods Pharma UK Limited - Irbesartan 150mg Film-coated tablets, PL 34771/0079 (MDR 94-06/18)

  24 Jan 2018 · Medicines recall/notification

  Class 2
• Field Safety Notice - 15 to 19 January 2018

  23 Jan 2018 · Field safety notice (devices)

• Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 (Service Pack) – Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension (MDA/2019/001)

  17 Jan 2018 · Device safety information

• Field Safety Notice - 8 to 12 January 2018

  15 Jan 2018 · Field safety notice (devices)

• All Philips HeartStart MRx monitors/defibrillators – significant delay in the supply of batteries

  15 Jan 2018 · Device safety information

• Pacemakers and CRT-P - oversensing of minute ventilation sensor signal leading to risk of syncope and pre-syncope

  12 Jan 2018 · Device safety information

• Field Safety Notice - 2 to 5 January 2018

  8 Jan 2018 · Field safety notice (devices)

• Class 2 Medicines Recall: Molipaxin 100 mg capsules (one batch)

  3 Jan 2018 · Medicines recall/notification

  Class 2
• Field Safety Notice - 27 to 29 December 2017

  2 Jan 2018 · Field safety notice (devices)

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